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Terminated

AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020.

FDA Recall Z-0839-2011 · Posted 2011-01-04

Recalling FirmAngioScore Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2010-11-16
Date Terminated2011-10-04
Product Quantity17682 units, all sizes and lots

Reason for Recall

Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.

Firm Action

Medical Device Recall notifications were sent to all domestic consignees on Nov 16, 2010 by overnight mail. Foreign distributors, other than Japan, were sent recall letters by e-mail or international overnight delivery on November 16, 2010. The Japanese distributor received notification and notified their customers on November 10, 2010.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: USA, China, Finland, Italy, Japan, Norway, Saudi Arabia, Spain, Sweden, Switzerland, UAE, United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103003AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEMAesculap, Inc. · 2010-11-09K080151ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039Angioscore, Inc. · 2008-04-25K072225ANGIOSCULPT PTA SCORING BALLOON CATHETERAngioscore, Inc. · 2007-10-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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